Novo Nordisk Initiates Phase III Clinical Trial of Oral Semaglutide for Weight Management in China

On April 6, Novo Nordisk registered a Phase III clinical trial (OASIS 3) on the Drug Clinical Trial Registration and Information Disclosure Platform to evaluate the efficacy and safety of once-daily oral semaglutide 50mg tablets in Chinese overweight or obese adults. This is the first Phase III weight-loss study of semaglutide tablets initiated by Novo Nordisk in China.

This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial, planning to enroll 200 adult subjects with a body mass index (BMI) ≥28.0kg/m² or BMI ≥24.0kg/m² accompanied by ≥1 weight-related comorbidity. The weight-related comorbidities should be hypertension, T2D, dyslipidemia, obstructive sleep apnea, or cardiovascular disease. Additionally, patients with a history of type 1 or type 2 diabetes are not included.

Patients in the trial group will be divided into five dose cohorts, namely 3 mg, 7 mg, 14 mg, 25 mg, and 50 mg dose groups, with treatment lasting for 44 weeks. The primary endpoints of the study are the relative change in body weight at week 44 and the proportion of subjects achieving a weight loss of ≥5% (yes or no).

Currently, the 7mg and 14mg dosages of semaglutide tablets have been approved in the United States for the treatment of type 2 diabetes. Last month, Novo Nordisk announced the blood sugar-lowering and weight-loss effects of 25mg and 50mg semaglutide tablets in people with type 2 diabetes. In individuals who adhered to semaglutide tablet treatment without the need for other type 2 diabetes medications, the 25mg and 50mg doses reduced body weight by 7.0kg and 9.2kg, respectively, demonstrating significantly superior weight loss compared to the 7mg and 14mg doses.

In June this year, Novo Nordisk will also release weight loss data of the 50mg dosage of semaglutide tablets in overweight or obese populations in the United States, Europe, and Japan (OASIS 1 study). The power of 50mg will be revealed then.

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